Enalapril Teva-Ratiopharm 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril Teva-ratiopharm 10 mg tablets

Enalapril maleate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Enalapril Teva-ratiopharm is and what it is used for
2. What you need to know before taking Enalapril Teva-ratiopharm
3. How to take Enalapril Teva-ratiopharm
4. Possible side effects
5. How to store Enalapril Teva-ratiopharm
6. Contents of the pack and other information

1. What Enalapril Teva-ratiopharm 10 mg is and what it is used for

Enalapril Teva-ratiopharm contains an active substance called enalapril maleate. It belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors.

Enalapril Teva-ratiopharm is used to:

• Treat hypertension (high blood pressure)
• Treat symptomatic heart failure (weakening of heart function). It may reduce the need for hospitalization and may help some patients live longer.
• Prevent signs of symptomatic heart failure. Signs include: shortness of breath, fatigue after mild physical activity such as walking, or swelling of the ankles and feet.

This medicine works by widening your blood vessels, thereby lowering your blood pressure. The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the maximum effect on blood pressure is observed.

2. What you need to know before taking Enalapril Teva-ratiopharm

Do not take Enalapril Teva-ratiopharm 10 mg

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor,
• if you have ever had swelling of the face, lips, mouth, tongue or throat causing difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you are more than 3 months pregnant. (It is also advisable to avoid this medicine early in pregnancy—see Pregnancy section.)
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is high.

Do not take this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Teva-ratiopharm

• If you have heart problems.

• If you have a disease affecting the blood vessels in the brain.

• If you have blood disorders such as low levels or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).

• If you have liver problems.

• If you have liver problems.

• If you have kidney problems (including after kidney transplant), follow a salt-free diet, take potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may lead to high potassium levels in the blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels. See also information under the heading “Taking Enalapril Teva-ratiopharm with other medicines”.

• If you are undergoing dialysis.

• If you have experienced excessive vomiting or severe diarrhoea recently.

• If you have diabetes. You should monitor your blood for low glucose levels, especially during the first month of treatment. Your blood potassium levels may also be higher.

• If you have ever had an allergic reaction with swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors.

• If you have low blood pressure (you may feel faint or dizzy, especially with initial doses and when standing up).

• If you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are being treated with medicines that suppress your immune system, or are taking allopurinol, procainamide, or any combination of these.

• If you are taking any of the following medicines, your risk of angioedema may increase:

  • racecadotril, a medicine used to treat diarrhoea.
  • medicines used to prevent organ transplant rejection and for cancer (e.g., sirolimus, everolimus, temsirolimus).
  • vildagliptin, a medicine used to treat diabetes.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as “sartans”—for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also information under the heading “Do not take Enalapril Teva-ratiopharm”.

Inform your doctor if you think you are pregnant (or could be). Enalapril Teva-ratiopharm is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

Please note that Enalapril Teva-ratiopharm is less effective in lowering blood pressure in black patients compared to non-black patients.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medicine.

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• any surgery or if you are to receive anaesthetics (including at the dentist),
• a treatment to remove cholesterol from your blood called “LDL apheresis”,
• a desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.

If any of the above apply to you, consult your doctor or dentist before undergoing the procedure.

Taking Enalapril Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal medicines. This is because enalapril may affect how other medicines work, and certain medicines may also affect how enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril Teva-ratiopharm” and “Warnings and precautions”).

• Other blood pressure-lowering medicines, such as blockers or diuretic tablets (“water pills”).

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., heparin, trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also information in the section “Warnings and precautions”.

• Medicines for diabetes (including oral antidiabetics and insulin).

• Lithium (a medicine used to treat certain types of depression).

• Medicines for depression called “tricyclic antidepressants”.

• Medicines for mental disorders called “antipsychotics”.

• Certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic medicine”.

• Certain medicines for pain or arthritis, including gold therapy.

• An mTOR inhibitor (e.g., sirolimus, everolimus, temsirolimus; medicines used to treat certain types of cancer or to prevent rejection of a transplanted organ). See section “Warnings and precautions”.

• A medicine containing sacubitril/valsartan, racecadotril or vildagliptin. These may increase the risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). See also “Do not take Enalapril Teva-ratiopharm” and “Warnings and precautions”.

• Non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain).

• Aspirin (acetylsalicylic acid).

• Medicines used to dissolve blood clots (thrombolytics).

• Alcohol.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medicine.

Taking Enalapril Teva-ratiopharm with food, drinks and alcohol

Enalapril may be taken with or without food. Most people take enalapril with a little water.

Pregnancy, breastfeeding and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative to enalapril. This medicine is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Breastfeeding is not recommended in newborns (first weeks after birth) and especially in premature infants while taking this medicine. For older infants, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments while breastfeeding.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this occurs, do not drive or operate tools or machinery.

Enalapril Teva-ratiopharm contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Enalapril Teva-ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is very important that you continue taking this medicine for as long as your doctor has prescribed it.

Do not take more tablets than prescribed.

The tablet can be divided into two equal doses.

Hypertension

The usual starting dose ranges from 5 to 20 mg taken once daily. Some patients may require a lower starting dose.

The usual long-term dose is 20 mg taken once daily.

The maximum long-term dose is 40 mg taken once daily.

Heart failure

The usual starting dose is 2.5 mg taken once daily. Your doctor will gradually increase the dose until the appropriate dose for your condition is reached.

The usual long-term dose is 20 mg per day, given in one or two doses.

The maximum long-term dose is 40 mg, divided into two daily doses.

Patients with kidney problems

Your dose will depend on how well your kidneys are functioning:

• moderate kidney problems - 5 mg to 10 mg per day
• severe kidney problems - 2.5 mg per day
• if undergoing dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, your dose may vary depending on how low your blood pressure is.

Use in children

Your doctor will determine the dose based on kidney function.

Paediatric population

Experience with the use of enalapril in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. Usual initial doses are:

• between 20 kg and 50 kg - 2.5 mg per day
• over 50 kg - 5 mg per day.

The dose may be adjusted according to the child's needs:

• a maximum of 20 mg per day may be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg per day may be used in children weighing over 50 kg.

This medicine is not recommended in newborns (first weeks after birth) or in children with kidney problems.

If you take more Enalapril Teva-ratiopharm than you should

If you take more enalapril than prescribed, contact your doctor or pharmacist immediately.

Take the medicine package with you.

In case of overdose, the most likely symptom is dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Enalapril Teva-ratiopharm

If you forget to take a tablet, do not take the missed dose.

Take the next dose at the usual time.

Do not take a double dose to make up for a missed dose.

If you stop taking Enalapril Teva-ratiopharm

Do not stop taking this medicine unless your doctor tells you to.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking this medicine and consult your doctor:

• swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing
• swelling of your hands, feet, or ankles
• if you develop a red rash on the skin with swelling (hives)

Please be aware that black patients have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking the medicine and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, lying down may help. This is due to a drop in your blood pressure. These symptoms will improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

Other adverse effects include:

Very common (may affect more than 1 in 10 people):

• dizziness, weakness, or vomiting
• cough
• blurred vision

Common (may affect up to 1 in 10 people):

• headache, depression, fainting (syncope), altered taste
• dizziness due to low blood pressure, chest pain, changes in heart rhythm, angina or chest pain
• difficulty breathing
• tiredness (fatigue)
• diarrhea, abdominal pain
• rash, allergic reactions with swelling of the face, extremities, lips, tongue, or throat with difficulty swallowing or breathing
• elevated potassium levels in blood, elevated creatinine levels in blood (both usually detected in a blood test)

Uncommon (may affect up to 1 in 100 people):

• anemia (including aplastic and hemolytic anemia)
• low blood glucose levels (hypoglycemia)
• confusion, drowsiness, or inability to sleep, nervousness
• itching or numbness sensation in the skin
• vertigo (dizziness)
• sudden drop in blood pressure
• rapid or irregular heartbeat (palpitations)
• myocardial infarction or stroke (possibly due to very low blood pressure in high-risk patients, even in those with impaired blood flow to the heart and/or brain)
• runny nose, sore throat, or hoarseness
• slow movement of food through the intestine (ileus), pancreatitis, vomiting, indigestion, constipation, anorexia
• gastric irritation (irritated stomach), dry mouth, ulcer
• increased sweating
• itching or hives
• hair loss
• reduced kidney function, kidney failure
• elevated protein levels in urine (detected in a test)
• impotence
• muscle cramps
• flushing
• ringing in the ears (tinnitus)
• malaise (general discomfort), elevated temperature (fever)
• increased blood urea, decreased sodium levels in blood
• low blood sugar or sodium levels, elevated blood urea levels (all detected in a blood test)

Rare (may affect up to 1 in 1,000 people):

• changes in blood values, such as lower numbers of white or red blood cells, lower hemoglobin levels, lower platelet count
• bone marrow suppression
• lymph node disease or abnormal immune response
• swollen glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• “Raynaud’s phenomenon” in which your hands and feet may become very cold and turn white due to reduced blood flow
• accumulation of fluid or other substances in the lungs (as seen on X-rays)
• nasal inflammation
• swelling of cheeks, gums, tongue, lips, throat
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin disorder in which you have red, peeling skin, blistering ulcers, or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• reduced daily urine output
• breast enlargement in men (gynecomastia)
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood test)

Very rare (may affect up to 1 in 10,000 people):

• intestinal angioedema (swelling in the intestine)

Frequency not known (frequency cannot be estimated from available data):

• overproduction of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion
• a symptomatic complex has been observed that may include all or some of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity, or other skin manifestations may also occur.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C. Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Teva-ratiopharm 10 mg tablets

• The active substance is enalapril (maleate). Each tablet contains 10 mg of enalapril (maleate).
• The other components are monohydrate lactose (lactose), corn starch, talc, sodium hydrogen carbonate, red iron oxide (E-172) and magnesium stearate.

Appearance of the medicine and contents of the pack

Enalapril Teva-ratiopharm is presented as round, biconvex, brownish-red tablets with a breakline. The tablet can be divided into two equal doses.

Each pack contains 10, 28, 60 or 500 tablets.

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren

Germany

Or

Teva Operations Poland Sp.z.o.o.

Mogilska 80

31-546 Kraków

Poland

Date of the most recent revision of this leaflet: September 2024

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

If your treatment with Enalapril Teva-ratiopharm 10 mg requires splitting the tablet, this is the best way to do it.

Place the tablet with the breakline facing upwards on a hard, flat surface (for example, a table or a plate). Place your index fingers (or thumbs) on either side of the breakline and press down briefly and firmly at the same time.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63816/P_63816.html